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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   37554   clinical trials with a EudraCT protocol, of which   6160   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2006-004193-27
    Sponsor's Protocol Code Number:NEU 112006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-004193-27
    A.3Full title of the trial
    A Double Blind, Parallel Group, Randomised, Placebo Controlled Study of Efficacy and Safety of CIRCADIN 2mg in the Treatment of Insomnia Patients with Low Endogenous Melatonin.
    A.3.2Name or abbreviated title of the trial where available
    Improvement in sleep latency in patients with primary insomnia
    A.4.1Sponsor's protocol code numberNEU 112006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNeurim Pharmaceuticals (1991) Ltd
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCIRCADIN
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typeSynthetic chemical product endogenous hormone
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary insomnia in adults with low endegenous melatonin.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    EU Version
    To assess the sustained long-term efficacy of Circadin 2 mg vs placebo for up to six months of treatment as assessed by changes from baseline in subjective sleep quality (as measured by the mean PSQI global score) during visits 6 and 7 (mean value) in all patients aged 55-80.

    US Version
    Following three weeks treatment with Circadin® 2 mg or placebo, to compare the change from baseline in subjective sleep latency (as measured by the sleep diary, question 3) in “low excretors”.
    E.2.2Secondary objectives of the trial
    EU Version
    In all patients aged 55-80 to compare:
    -change from baseline in mean subjective sleep latency (as measured by question 2 of the PSQI at visits 6, 7).
    -change from baseline in quality of life (as measured by the WHO-5 scale at visits 6, 7).
    -Clinical Global Impressions (CGI) global improvement at visits 6 and 7.
    -To assess withdrawal effect after discontinuation (as measured by the Tyrer scale) of Circadin vs placebo following 6 months of treatment.

    US Version
    Following three weeks treatment with Circadin® 2 mg or placebo, to compare:
    -change from baseline in subjective sleep latency (Sleep Diary, question 3) patients aged 65-80 inclusive.
    -change from baseline in “low excretors” compared to “high excretors” on efficacy variables in different age bands
    -the rate of responders in patients aged 55 to 80
    -To assess safety parameters in the total population following three weeks treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • male or female and aged 18-80 years
    • willing to take a 6-SMT level evaluation test
    • suffering from primary insomnia according to DSM-IV criteria (307.42 primary insomnia, Appendix 24.3) (Based on a Sleep History Questionnaire that is given to the patient before Visit 1, Appendix 24.9)
    • sleep latency of at least 20 minutes
    • have not been using BZD and non-BZD hypnotics for the past 2 weeks or more
    • have not been using psychotropic treatments for the past 3 months or more
    • are stabilized on non-psychotropic treatments for more than 1 month
    • are willing to sign a written informed consent to participate in the study

    Patients completing the two week placebo baseline/screening who continue to meet the entry criteria and who fulfill the following will be eligible to be randomisedrandomized if:

    • Negative drug screen (BZD or opiates). Where the patient has reported use of opiate analgesics for pain relief (not hypnosis) at visit 1 the opiate screen may be positive and the patient still randomised.
    • No reported use of BZD and non-BZD hypnotics, antihistamines or psychotropic treatments during the two-week placebo baseline/screening period
    • A good compliance during the two-week placebo baseline/screening period defined as 70% to 130% of prescribed tablets
    • Correct use of the Diary and Leeds SEQ
    E.4Principal exclusion criteria
    • Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.
    • Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.
    • Pharmacological immunosuppression
    • Participation in a clinical trial with any investigational agent within two months prior to study enrollment
    • According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition)
    • Severe neurological, psychiatric disorders especially psychosis, anxiety and depression and alcoholism
    • Other serious diseases that could interfere with patient assessment
    • Pregnant or breast feeding women
    E.5 End points
    E.5.1Primary end point(s)
    EU Version
    To assess the sustained long-term efficacy of Circadin 2 mg vs placebo for up to six months of treatment as assessed by changes from baseline in subjective sleep quality (as measured by the mean PSQI global score) during visits 6 and 7 (mean value) in all patients aged 55-80.

    US Version
    Following three weeks treatment with Circadin® 2 mg or placebo, comparison of the change from baseline in subjective sleep latency (as measured by the Sleep Diary, question 3) in “low excretors”.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state850
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Referral back to primary care physian if appropriate
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-21
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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